Recall Z-1484-2018— Draeger Medical, Inc.

Name: FDA recall Z-1484-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-01

Class I · Terminated

Class I FDA medical device recall by Draeger Medical, Inc., initiated 2018-03-01, terminated 2019-04-16. It names one FDA 510(k) clearance: K042419. Product: Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).. Reason: The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail..

Recalling firm: Draeger Medical, Inc.
Classification: Class I
Status: Terminated
Initiated: 2018-03-01
Terminated: 2019-04-16
Firm location: Telford, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K042419 — FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEMDraeger Medical, Inc.·cleared 2004-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Fabius Tiro M, anesthesia machine, catalog no. 8608400 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).

Reason for recall

The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

Data sourced from openFDA. This site is unofficial and independent of the FDA.